BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    REVISED LABELING FOR METHAQUALONE TEST KIT

    K Number: K874272 · Decision Nov 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    296
    Review Days
    24

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    Basic Information

    Device Name
    REVISED LABELING FOR METHAQUALONE TEST KIT
    K Number
    K874272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3630
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    October 20, 1987
    Decision Date
    November 13, 1987
    Product Code
    KXS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KXS Radioimmunoassay, Methaqualone

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